Senior CRA

Roles & Responsibilities:

• Perform site monitoring using a risk-based monitoring approach
• Apply root cause analysis (RCA) and critical thinking to identify site issues and implement CAPAs
• Ensure data accuracy through SDR, SDV, and CRF review (on-site and remote)
• Review investigational product accountability, inventory, and records
• Prepare monitoring reports and follow-up letters within defined timelines
• Escalate site issues to clinical management and ensure timely resolution
• Maintain regular communication with sites between monitoring visits
• Support investigator payments and follow-up on site findings
• Participate in investigator meetings and site selection activities
• Conduct site initiation, close-out visits, and trial material reconciliation
• Ensure essential documents comply with ICH-GCP and regulatory requirements
• Update CTMS and provide trial progress reports to Clinical Team Manager
• Contribute to process improvement initiatives and project team activities

Qualification:

• University degree in a science-related field

Experience:

• CRA qualification as per Ministerial Decree dated 15/11/2011
• Minimum 3 years of independent monitoring experience (Phase II–IV)
• Experience in Pharma, Biotech, or CRO environments

Skills:

• Strong clinical monitoring and site management skills
• Excellent knowledge of ICH-GCP, EU, and FDA regulations
• Risk-Based Monitoring expertise
• Strong root cause analysis and problem-solving abilities
• Excellent communication skills in English and Italian
• Ability to work independently and within cross-functional teams
• Strong organizational, time management, and documentation skills
• Proficiency in MS Office and clinical trial systems
• Valid driver’s license

About The Organization:

Thermo Fisher Scientific is a global leader in life sciences and clinical research, with annual revenue exceeding $44 billion and a workforce of over 90,000 employees. The company supports 2,700+ clinical trials across 100+ countries, enabling customers to make the world healthier, cleaner, and safer.